Ethicon Endo-Surgery ENDOPATH Electrosurgery Probe Plus II 34 cm Spatula Probe (Product Code EPS02)
This recall has been terminated (originally issued January 27, 2009).
- Company
- Ethicon Endo-Surgery Inc
- Recall Initiated
- December 9, 2008
- Posted
- January 27, 2009
- Terminated
- October 20, 2010
- Recall Number
- Z-0656-2009
- Quantity
- 32 lots, 18,528 pieces
- Firm Location
- Cincinnati, OH
- Official Source
- View on FDA website ↗
Reason for Recall
Nickel exposure: The stainless steel tips on the affected product were degrading, causing a small amount of nickel to be released, which may lead to health risks in some patients, particularly those with a known or suspected nickel allergy or sensitivity. Ethicon Endo-Surgery determined the presence of free nickel in the affected product could elicit a reaction in those patients with nickel sens
Distribution
Worldwide distribution: USA, PUERTO RICO, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, CHINA, COLOMBIA, DOMINICAN REPUBLIC, EGYPT, ENGLAND, EQUADOR, GERMANY, GREECE, INDIA, INDONESIA, ISRAEL, ITALY, JAPAN, KOREA, MALAYSIA, MEXICO, PAKISTAN, PANAMA, POLAND, REPUBLIC OF YEMEN, RUSSIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD, TURKEY, UNITED ARAB EMIRATES, URUGUAY, and VENEZUELA.
Lot / Code Info
Product Code EPS02 - Lot # E4K181, Exp. Date 2012-12; Lot # E4K58C, Exp. Date 2012-12; Lot # E4KC5X, Exp. Date 2013-01; Lot # E4KD1P, Exp. Date 2013-01; Lot # E4KF2N, Exp. Date 2013-01; Lot # E4KG70, Exp. Date 2013-01; Lot # E4KK22, Exp. Date 2013-02; Lot # E4KP2F, Exp. Date 2013-02; Lot # E4KV17, Exp. Date 2013-03; Lot # E4KY1A, Exp. Date 2013-03; Lot # E4KY70, Exp. Date 2013-03; Lot # E4L03H, Exp. Date 2013-04; Lot # E4L519, Exp. Date 2013-04; Lot # E4L73Z, Exp. Date 2013-05; Lot # E4L916, Exp. Date 2013-05; Lot # E4LC3K, Exp. Date 2013-05; Lot # E4LD8L, Exp. Date 2013-05; Lot # E4LF60, Exp. Date 2013-05; Lot # E4LG4D, Exp. Date 2013-06; Lot # E4LL7P, Exp. Date 2013-06; Lot # E4LT6E, Exp. Date 2013-07; Lot # E4LX4H, Exp. Date 2013-07; Lot # E4M045, Exp. Date 2013-08; Lot # E4M12L, Exp. Date 2013-08; Lot # E4M27N, Exp. Date 2013-08; Lot # E4M466, Exp. Date 2013-08; Lot # E4M535, Exp. Date 2013-08; Lot # E4M54F, Exp. Date 2013-08; Lot # E4M69H, Exp. Date 2013-09; Lot # E4M838, Exp. Date 2013-09; Lot # E4MA4M, Exp. Date 2013-09; and Lot # E4MC3A, Exp. Date 2013-09
Root Cause
Process design
Action Taken
On 12/9/2008 Ethicon Endo-Surgery sent recall notification letters to their customers instructing them to stop using the product, examine all inventory to determine if they have the affected product on hand and remove the affected products from inventory. They requested that each customer complete the Business Reply Form and fax it back to Stericycle and also return any affected product to Stericycle.